FDA Approves Prior Approval Supplement for BIVIGAM®
ADMA Biologics Inc (ADMA)
Last adma biologics inc earnings: 3/12 04:05 pm
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ir.admabiologics.com
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Source: GlobeNewswire
RAMSEY, N.J. and BOCA RATON, Fla., May 10, 2019 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”), a vertically integrated commercial biopharmaceutical and specialty immunoglobulin company that manufactures, markets and develops specialty plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases, announces that the U.S. Food and Drug Administration (“FDA”) has approved the Company’s Prior Approval Supplement (“PAS”) for BIVIGAM® (immune globulin intravenous (human), 10% liquid). The FDA’s approval of the PAS for BIVIGAM® approves the use of the Company’s optimized intravenous immune globulin (“IVIG”) manufacturing process and enables ADMA to commence the marketing of BIVIGAM® in the U.S. to patients with Primary Humoral Immunodeficiency (“PI”). “This FDA approval for ADMA’s third commercial product is a significant milestone, and we look forward to commencing sales of BIVIGAM® in the n
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ADMA
Earnings
- 2/28/24 - Miss
ADMA
Sec Filings
- 4/15/24 - Form ARS
- 4/15/24 - Form DEFA14A
- 4/15/24 - Form DEF
- ADMA's page on the SEC website